A Study Of Avelumab In Combination With Axitinib In Advanced Renal Cell Cancer (JAVELIN Renal 100)

NCT02493751

About this Study

This is a Phase 1b, open-label, multi-center, multiple-dose trial designed to estimate the
maximum tolerated dose (MTD) and select the recommended phase 2 dose (RP2D) of avelumab
(MSB0010718C) in combination with axitinib (AG-013736). Once the MTD of avelumab administered
in combination with axitinib is estimated (dose finding portion), the dose expansion phase
will be opened to further characterize the combination in term of safety profile, anti tumor
activity, pharmacokinetics, pharmacodynamics and biomarker modulation.

- Availability of a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block
from a de novo tumor biopsy during screening (biopsied tumor lesion should not be a
RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue
block (not cut slides) from a primary or metastatic tumor resection or biopsy can be
provided if the following criteria are met: 1) the biopsy or resection was performed
within 1 year of enrollment AND 2) the patient has not received any intervening
systemic anti-cancer treatment from the time the tissue was obtained and enrollment
onto the current study. If an FFPE tissue block cannot be provided as per documented
regulations,, 15 unstained slides (10 minimum) will be acceptable.

- Availability of an archival FFPE tumor tissue block from primary diagnosis specimen
(if available and not provided per above). If an FFPE tissue block cannot be provided,
15 unstained slides (10 minimum) will be acceptable

- At least one measureable lesion as defined by RECIST version 1.1 that has not been
previously irradiated.

- Age ≥18 years (≥ 20 years in Japan).

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Adequate bone marrow function, renal and liver functions

Exclusion criteria

The factors, or reasons, that prevent a person from participating in a clinical study.

Show details

- Prior systemic therapy directed at advanced RCC.

- Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has
occurred during or within 12 months after the last dose of treatment

This is a Phase 1b, open-label, multi-center, multiple-dose trial designed to estimate the maximum tolerated dose (MTD) and select the recommended phase 2 dose (RP2D) of avelumab (MSB0010718C) in combination with axitinib (AG-013736). Once the MTD of avelumab administered in combination with axitinib is estimated (dose finding portion), the dose expansion phase will be opened to further characterize the combination in term of safety profile, anti tumor activity, pharmacokinetics, pharmacodynamics and biomarker modulation.

Detailed Description

Not Provided

Study Type ICMJE

Interventional

Study Phase

Phase 1

Study Design ICMJE

Masking: None (Open Label)Primary Purpose: Treatment

Condition ICMJE

Renal Cell Cancer

Intervention ICMJE

Drug: Avelumab (MSB0010718C)

Avelumab with two dose levels: 10 mg/kg IV and 5 mg/kg IV every two weeks to find the maximum tolerated dose in combination with axitinib and continue treatment in a dose expansion.

Drug: Axitinib (AG-013736)

Axitinib with two dose levels: 5 mg and 3 mg oral BID to find the maximum tolerated dose in combination with avelumab and continue treatment in a dose expansion.

Study Arms

Experimental: Dose finding phase and dose expansion phase.

To test the maximum tolerated dose of avelumab (MSB0010718C) in combination with axitinib (AG-013736)

Interventions:

Drug: Avelumab (MSB0010718C)

Drug: Axitinib (AG-013736)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Availability of a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy during screening (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides) from a primary or metastatic tumor resection or biopsy can be provided if the following criteria are met: 1) the biopsy or resection was performed within 1 year of enrollment AND 2) the patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and enrollment onto the current study. If an FFPE tissue block cannot be provided as per documented regulations,, 15 unstained slides (10 minimum) will be acceptable.

Availability of an archival FFPE tumor tissue block from primary diagnosis specimen (if available and not provided per above). If an FFPE tissue block cannot be provided, 15 unstained slides (10 minimum) will be acceptable

At least one measureable lesion as defined by RECIST version 1.1 that has not been previously irradiated.

Age ?18 years (? 20 years in Japan).

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Adequate bone marrow function, renal and liver functions

Exclusion Criteria:

Prior systemic therapy directed at advanced RCC.

Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred during or within 12 months after the last dose of treatment